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Posted On: 10/17/2020 11:15:16 PM
Post# of 149015
"Going by FDA guidance the DSMC would be the only ones to know what the mortality reduction was unless the trial was halted. If the trial was just under the predetermined mortality endpoint the report to Cytodyn might read something like "predetermined p value was not achieved but trial should continue.". Cytodyn would have no idea how close we are. "
If Seethamraju is correct that the FDA reviewed unblinded CD12 interim data, I don't think there exists any FDA guidance for that situation.
If Seethamraju is correct all of the published FDA protocols are gone out the window.
Its possible that the CD12 interim analysis may be in an unprecedented situation: FDA is unblinded and CYDY remains blinded.
Perhaps the FDA can unblind themselves without assessing any penalty to CYDY.
If Seethamraju is correct that the FDA reviewed unblinded CD12 interim data, I don't think there exists any FDA guidance for that situation.
If Seethamraju is correct all of the published FDA protocols are gone out the window.
Its possible that the CD12 interim analysis may be in an unprecedented situation: FDA is unblinded and CYDY remains blinded.
Perhaps the FDA can unblind themselves without assessing any penalty to CYDY.
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